GE MAC 5 A4 and A5 Resting ECG Analysis Systems
GE is recalling MAC 5 A4 and A5 ECG systems due to a software error that may incorrectly associate clinical data with the wrong patient.
Contact your GE HealthCare representative or service provider to arrange for a software update to the correct production version.
Why it was recalled
GE Medical Systems is recalling certain Resting ECG Analysis Systems because software in development was inadvertently made available for customer use. This software version may cause clinical information to be associated with the incorrect patient, potentially impacting clinical decision-making.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
- UPC
- 00195278276070, 00195278276124
- Recall #
- Z-2306-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification